To establish what factors are important for patients to engage in a new intervention for chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME) and make recommendations to general practitioners (GPs) on preparing a patient for referral to such a service.

BACKGROUND:

NICE guidelines recommend a prominent role for primary care in the management of patients with CFS/ME, with prompt diagnosis and appropriate referral for evidence-based treatments.

METHODS:

A qualitative study nested within a multi-centre randomised controlled trial of two new nurse therapist delivered interventions.

Semi-structured interviews carried out with 19 patients who had received pragmatic rehabilitation (PR) in the trial.

Interviews were transcribed verbatim and an iterative approach used to develop themes from the data set.

FINDINGS:

Factors that influence whether or not a patient engages with PR for CFS/ME are ensuring that the patient feels accepted and believed, that they accept the diagnosis, and that the model implicated by the treatment offered to the patient matches the model of illness held by the patient.

If patients hold a clearly incompatible model of their illness, it is unlikely that they will engage with, and successfully complete, therapy.

It is vital that the GP elicits and explores such illness beliefs either before making a referral to maximise patient engagement in therapy, or that an initial session with the therapist explores attitudes to the treatment model offered and then works with the patient's model.

There is considerable evidence that when people experience a threat to their health such as symptoms or chronic illness, they are motivated to form an understanding or personal model of that threat, to guide their attempts to neutralise the threat, that is to get well (Leventhal et al., 1984). In the case of CFS/ME, where there is no medical explanation for fatigue and often no treatment advice forthcoming, patients struggle to make sense of their illness, and may develop models of their illness in which ﬂuctuating symptoms are interpreted as evidence of bodily damage or relapse (Deary et al., 2007). Cognitive behavioural approaches to CFS/ME may help patients consider whether their personal model of their illness is helpful for them in their attempts to become well.

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Part 1 of underlined bit: the symptoms could be a sign of relapse

Part 2 of underlined bit: CBT approaches to CBT/ME tend to be more directive than they are saying, with not all personal models being acceptable.

Pragmatic rehabilitation (PR) is a therapist facilitated self-management intervention for CFS/ ME, which shares features in common with CBT and GET, but which does not require a specialist CBT or physiotherapist to deliver it. PR conceptualises the symptoms experienced by people with CFS/ME as a consequence of physiological dysregulation, including cardiovascular and muscular deconditioning and disruption of sleep– wake cycles. PR differs from conventional CBT in that the treatment starts with an explicit presentation of the PR explanatory model for CFS/ME, supported by a referenced manual. Treatment involves a graded activity schedule carefully monitored to be well within the patient’s abilities, with gradual increments, regularisation of sleep, and the collaborative development of plans working towards rehabilitation (Wearden and Chew-Graham, 2006). There is evidence that PR is effective in secondary care (Powell et al., 2001) and a recent trial (Wearden et al., 2006) suggests that PR is effective for some patients in primary care, but the effect is not sustained (Wearden et al., 2010).

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The underlined bit is talking about the FINE Trial results. "Effective" is probably overstating it.

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Results:
Table 3 has some results (remember these aren't all the results).

SF-36 physical functioning scores

If take the 17 where we have results before and after:
Before:Mean 30.88SD 16.61SEM 4.03N 17 90% CI 23.85 to 37.9195% CI 22.34 to 39.4299% CI 19.12 to 42.65Minimum 0Median 30Maximum 60

It is interesting to see how many of the patients were sucked in, because the therapists were sympathetic and listened to them etc (see Results: "Feeling accepted by the therapist" and also "Own acceptance of diagnosis")

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However, not all the patients were uncritical by the end:

But the other thing that upsets me about that is that when the nurse came round and explained the theory to me, it was sold to me as fact, this is what is happening, there was no element of this is actually quite a contentious issue, I have done some research since and found evidence supporting both camps and there was no part of that session that said there are some people that don’t believe this.

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Several patients held a model of the illness, which
implied that activity was potentially damaging, so
patients were fearful of relapse.

Well the sections here [in the manual], I havemarked them, like the section here that I didn’treally agree with and I tried to tell her that Ididn’t agree, erm, like it says there is no hiddendisease, I think there could be somethingthat they haven’t found you know. But activity/exercise cannot harm you, I think it canharm you, if you are not good and you really,really push yourself you can relapse, definitely.And I did try to tell her that, but I thinkshe was, rigid to the book and she thought thatwas exact, I didn’t.

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It is unworkable in my opinion. From, I mean I went into this feeling very positive, feeling that I understood the theory, and feeling that it made sense and its something that I wanted to work for me and it was good for me because it made me think right I can take this into my own hands, I can make myself better, but I don’t believe the fundamentals are right and you know, one of the most documented things about this illness is the delayed effect of activity and you know that is quite a basic principle and so is the principle of resting for 10 minutes and then you know you are within your limits and they don’t go together at all.

Factors that influence whether or not a patient engages with PR for CFS/ME are ensuring that the patient feels accepted and believed, that they accept the diagnosis, and that the model implicated by the treatment offered to the patient matches the model of illness held by the patient.

If patients hold a clearly incompatible model of their illness, it is unlikely that they will engage with, and successfully complete, therapy.

The authors basically blame the patients for it not working. They also say GPs can be problems.

Thus, we suggest that a patient needs to feel that they are believed and understood by the therapist before engaging in the treatment offered. Engagement can help the patient accept their own illness and formulate an adequate explanation for the symptoms experienced. If the patient’s model of illness, either pre-existing or so formulated, is in agreement with that of the therapist, the patient feels further reassured that the therapist has a real and genuine understanding of them and their condition and thus continues to engage in the treatment. Similarly, where models of treatment match, the patient will engage with the intervention. If, however, there is no matching of the patient’s model of the cause of their symptoms of the model of treatment offered, engagement and working with the intervention offered is unlikely.

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They don't mention that a patient can agree with the theory, or be willing to give it a try, but their body "doesn't agree"/"can't cope" with the suggestions

A number of respondents rejected the inflexibility of the presentation of the model, and this may be due to the intervention being presented within a randomised controlled trial, and may be less of an issue in development of a service based on this model of intervention, where more flexibility could be offered.

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I'm not sure how true this is in this case, unless they are willing for patients not to stick to the suggestions.

An important aspect of the process of engaging patients and forming a therapeutic alliance with them is the development of an agreed model of the patients’ problems, which provides the rationale for shared, collaborative goals for treatment. We know from other conditions that when patients and their doctors share an explanatory model, patients are more satisfied with their treatment (Callan and Littlewood, 1998).

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However, these models for ME/CFS with manuals are prescriptive. The only model allowed is the one in the manual.

Previous work with the pragmatic rehabilition model has shown that it can be very effective in helping patients to get better (Powell et al., 2001), but this study suggests that if the model is not believed by patients, it is less effective (Wearden et al., 2010).

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They didn't really show that the current study showed this. They just quoted various patients, but didn't show any correlation with outcome or really talk about this i.e. didn't say: here's a patient who did well and here is what they said, etc.

A further factor influencing the extent to which interventions are perceived as acceptable by patients is the degree to which the models of the illness held by patient and clinician match. The association between beliefs about illness and illness outcomes is well established (Hagger and Orbell, 2003) and interventions need to take into account existing beliefs, patient’s past experience and prior ways of managing illness. If the GP does not have a model of illness for CFS/ME, has difficulty or reluctance in making the diagnosis of CFS/ME (Chew-Graham et al., 2010) then successful initial management in primary care and appropriate referral will be unlikely.

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I don't recall any quotes from patients about what their GPs said. It may be true that GPs may not diagnose or refer for the reasons they give, but don't believe they have shown much about a GP's attitude influencing the outcome.

(minor)

Clinical implications This study has important implications, not just for the management of people with CFS/ME, but also for the patients with other medically unexplained symptoms (MUS), or psychological symptoms that are not easily categorised by current diagnostic systems. Given that the Improving Access to Psychological Therapies (IAPT) initiative (Department of Health, 2008) is being proposed as a model for dealing with patients with MUS, these findings are relevant to the referral pathways and treatment models offered.

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I thought it might be somewhat interesting in terms of understanding all patients and how they engage with therapy.

The authors basically blame the patients for it not working. They also say GPs can be problems.

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This is classic cognitive dissonance at play. The psycho-social school are so confident their model is correct that when data suggests it might not be, they have to find reasons for the discordance that don't involve modifying their own beliefs.

Imagine the panic when they found out that, having promised "100% recovery" in patients who have "no disease", their therapy was no better than a few trips to the GP.

Within the 17 for whom we have both figures, although overall there was a big increase, three deteriorated:
10->0
35->0
55->45

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Are these SF36 Physical Function scores?

If so - a score 0f 0 can indicate that the person is housebound or chairbound and needs help with personal care or that the person is bedbound or worse. This scale does not distinguish this well , IMO.

Within the 17 for whom we have both figures, although overall there was a big increase, three deteriorated:
10->0
35->0
55->45

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Are these SF36 Physical Function scores?

If so - a score 0f 0 can indicate that the person is housebound or chairbound and needs help with personal care or that the person is bedbound or worse. This scale does not distinguish this well , IMO.

I accept your point, but a lot of generic questionnaires will have problems and probably the floor effects are not so bad compared to many (it's certainly worse for the SF-36 role physical, where lots of people with ME/CFS would score zero).

For anyone who doesn't know, to score 0, one would need to answer "yes, limited a lot" to all 10 of these questions:

The following items are about activities you might do during a typical day. Does your health now limit you in these activities? If so, how much? (check one on each line)

ACTIVITIES

Yes, Limited A Lot --- Yes, Limited A Little --- No, Not Limited At All

Previous work with the pragmatic rehabilition model has shown that it can be very effective in helping patients to get better (Powell et al., 2001), but this study suggests that if the model is not believed by patients, it is less effective (Wearden et al., 2010).

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They didn't really show that the current study showed this. They just quoted various patients, but didn't show any correlation with outcome or really talk about this i.e. didn't say: here's a patient who did well and here is what they said, etc.

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So, the original, small study (Powell, 2001) showed spectacular improvements while the larger and more rigorous study - set up specifically to validate this approach - showed no sustained effect. The conventional interpretation of this situation would be that the bigger and better validating study trumps the initial one, and the treatment doesn't work.

As Dolphin says, they also provided no evidence that patient beliefs were any different in the original trial.

Thanks for posting this and the other extracts, Dolphin, really valuable to get some direct patient views.

Given that the Improving Access to Psychological Therapies (IAPT) initiative (Department of Health, 2008) is being proposed as a model for dealing with patients with MUS, these findings are relevant to the referral pathways and treatment models offered.

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Shouldn’t that be the Improving Access to Testing and Diagnosis Initiative? I would think the first thing you would want to do with medically unexplained symptoms is explain them.